Iressa v BSC (Best Supportive Care) in First Line NSCLC

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed NSCLC

• NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy

• Not suitable for chemotherapy

• WHO Performance status 2 or 3

Exclusion Criteria:

• Newly diagnosed CNS mets

• Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity

• Other co-existing malignancies

• ALT/AST greater than 5 x upper limit of normal

• ANC less than 1.0 x 109/L or platelets less than 100 x 109/L